Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Primary Purpose
Intermittent Claudication
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cilostazol 100 mg
PMR 150 mg
PMR 200 mg
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Claudication focused on measuring Peripheral Artery Disease, Cilostazol, PMR, Extended-Release Tablet of Cilostazol
Eligibility Criteria
Inclusion Criteria:
- Must be 18 to 45 years of age, inclusive.
- Absence of diseases, such as heart failure, significant kidney impairment or a history of restricted blood flow to the heart, that could affect the study outcomes.
- Having a body mass index (BMI) within normal standard limits (18.5~24.9, inclusive).
- Willing and able to give informed consent to participate in the clinical study and comply with all study procedures, restrictions and attend all visits.
Exclusion Criteria:
- History of bleeding tendency.
- Use of anticoagulant agent(s) within 1 month prior to screening.
- Use of tobacco or nicotine products within 6 months of screening.
- Intake of over the counter or prescription drugs (other than hormonal contraceptives) within 2 weeks prior to randomization.
- On any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or anticipating use of any of these therapies during the course of the study (other than the study products).
- History of substance abuse, such as alcohol, IV drugs, and inhaled drugs, within 1 year prior to screening.
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or positive pre-study result of infection with Human Immunodeficiency Virus (HIV); history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Pregnant or breast feeding.
Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria:
- Post-menopausal: 12 months of natural (spontaneous) amenorrhea or less than 12 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40IU/L, OR;
- 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR;
- Using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation), hormonal contraception (e.g. implantable, injectable, vaginal patch, and oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study discontinuation.
- Known or suspected hypersensitivity to any ingredient of study drug(s).
- Donated blood or lost more than 150 mL of blood within 3 months prior to randomization or plans to donate blood or plasma within 4 weeks after completion of the study.
Sites / Locations
- Bio-Kinetic Clinical Applications, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Cilostazol 100 mg
PMR 150 mg
PMR 200 mg
Arm Description
Outcomes
Primary Outcome Measures
Area under the curve, from time zero to last measureable time point (AUC (0-t))
AUC from time zero to infinity (AUC (0-∞))
Secondary Outcome Measures
Full Information
NCT ID
NCT03480321
First Posted
March 5, 2018
Last Updated
July 9, 2018
Sponsor
Genovate Biotechnology Co., Ltd.,
1. Study Identification
Unique Protocol Identification Number
NCT03480321
Brief Title
Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Official Title
An Open-Label, Randomized, Three-Treatment, Three-Way Crossover Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
April 28, 2018 (Actual)
Study Completion Date
June 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genovate Biotechnology Co., Ltd.,
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is designed to evaluate the bioequivalency between the test formulations of extended-release tablet of cilostazol (PMR) administered once-daily and the reference formulation of immediate-release tablet of cilostazol (Cilostazol) administered twice-daily in normal healthy male and female subjects under fasting conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Claudication
Keywords
Peripheral Artery Disease, Cilostazol, PMR, Extended-Release Tablet of Cilostazol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cilostazol 100 mg
Arm Type
Active Comparator
Arm Title
PMR 150 mg
Arm Type
Experimental
Arm Title
PMR 200 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cilostazol 100 mg
Intervention Description
One immediately-release tablet (Cilostazol 100 mg) at 08:00 and another at 20:00, twice daily oral dose (total daily dose of 200 mg)
Intervention Type
Drug
Intervention Name(s)
PMR 150 mg
Intervention Description
Two extended-release tablets (PMR 150 mg) at 08:00, single oral dose (total daily dose of 300 mg)
Intervention Type
Drug
Intervention Name(s)
PMR 200 mg
Intervention Description
Two extended-release tablets (PMR 200 mg/tablet) at 08:00, single oral dose (total daily dose of 400 mg)
Primary Outcome Measure Information:
Title
Area under the curve, from time zero to last measureable time point (AUC (0-t))
Time Frame
0-72 hours after morning dose
Title
AUC from time zero to infinity (AUC (0-∞))
Time Frame
0-72 hours after morning dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must be 18 to 45 years of age, inclusive.
Absence of diseases, such as heart failure, significant kidney impairment or a history of restricted blood flow to the heart, that could affect the study outcomes.
Having a body mass index (BMI) within normal standard limits (18.5~24.9, inclusive).
Willing and able to give informed consent to participate in the clinical study and comply with all study procedures, restrictions and attend all visits.
Exclusion Criteria:
History of bleeding tendency.
Use of anticoagulant agent(s) within 1 month prior to screening.
Use of tobacco or nicotine products within 6 months of screening.
Intake of over the counter or prescription drugs (other than hormonal contraceptives) within 2 weeks prior to randomization.
On any investigational drug(s) or therapeutic device(s) within 30 days preceding screening; or anticipating use of any of these therapies during the course of the study (other than the study products).
History of substance abuse, such as alcohol, IV drugs, and inhaled drugs, within 1 year prior to screening.
Known history of having Acquired Immunodeficiency Syndrome (AIDS) or positive pre-study result of infection with Human Immunodeficiency Virus (HIV); history or positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
Pregnant or breast feeding.
Women of child-bearing potential not using an effective birth control method. Women of child-bearing potential are defined as women physiologically capable of becoming pregnant, UNLESS they meet the following criteria:
Post-menopausal: 12 months of natural (spontaneous) amenorrhea or less than 12 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40IU/L, OR;
6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, OR;
Using one or more of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation), hormonal contraception (e.g. implantable, injectable, vaginal patch, and oral), and double-barrier methods. Reliable contraception should be maintained throughout the study and for 7 days after study discontinuation.
Known or suspected hypersensitivity to any ingredient of study drug(s).
Donated blood or lost more than 150 mL of blood within 3 months prior to randomization or plans to donate blood or plasma within 4 weeks after completion of the study.
Facility Information:
Facility Name
Bio-Kinetic Clinical Applications, LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pharmacokinetic Study of Once Daily PMR Compared to Twice Daily Cilostazol IR Tablets in Healthy Volunteers
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